CLASS II ONGOING Device recall · Reported 30 Dec 2020 · FDA Enforcement Report
Baxter Sigma Spectrum Infusion Pump with Master Drug Library recalled
Baxter Healthcare is recalling Baxter Sigma Spectrum Infusion Pump with Master Drug Library (, distributed nationwide in the US. The recall was initiated on 23 Nov 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0713-2021
- FDA event ID
- 86758
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Nov 2020
- FDA classified
- 23 Dec 2020
- Reported
- 30 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Infusion Pumps
Timeline
| 23 Nov 2020 | Recall initiated by company | |
| 23 Dec 2020 | Classified by FDA | +30 days |
| 30 Dec 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential software error during programming.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
Where it was distributed
Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.
Questions about this recall
Is Baxter Sigma Spectrum Infusion Pump with Master Drug Library ( recalled?
Yes. Baxter Healthcare recalled Baxter Sigma Spectrum Infusion Pump with Master Drug Library ( on 23 Nov 2020. The recall is Class II and its status is Ongoing. Recall number Z-0713-2021.
Why was it recalled?
There is a potential software error during programming.
Which lots are affected?
Product Code 35700BAX, GTIN 00085412091587
Where was it sold?
Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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